Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Asan Medical Center
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Updated on 19 February 2024
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Summary

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Description

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Details
Condition Cryptogenic Stroke, High Risk Patent Foramen Ovale
Age 60years - 100years
Treatment Percutaneous device closure
Clinical Study IdentifierNCT04285918
SponsorAsan Medical Center
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients 60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)
Patients 60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board
Patients who are scheduled to have implantable cardiac monitoring

Exclusion Criteria

Transient ischemic attack
Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)
Presence of complex aortic atheroma (4mm in plaque thickness or presence of mobile components)
Presence of 50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area
Unwillingness or inability to comply with the procedures described in this protocol
Life expectancy < 1 years for any non-cardiac or cardiac causes
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